icable worldwide?

(i) Copyright
(iv) Trademark
d with a com-
History and Evolution
of Patent Law 2
(ii) TS
iv) SM

Chapter objectives
As we have studied the importance of
property plays an important role in the intellectual property rights, we know that this form off
why diferent countries have tecihnological progress of the country. This is the reason
different patent laws. The patent lavs have
changes across the world in the witnessed revolutionary
past several decades. In this
of origin of
patents, evolution of patent laws, Indian chapter will study the concept
we

international conventions, treaties patent laws with several amendments,

in various other and legislative framework, and the patent laws
countries. The chapter also prevailing
other countries summarizes the difference between
with reference to IPL (Indian Patent Laws) and US laws.
patent laws of
on?
dia for IPR?
EVOLUTION OF PATENT LAVWs
The origin of patent is obscure but it is
ring filing of the Republic of Venice issued a patent for a generally considered to have evolved in Italy in 1474 when
by the Republic of Florence in 1421. period of 10 years. The first Italian patent was
ancient Greek cities. Some 500 Evidence also indicates that there existed actually awarded
B.C., in the Greek
city named something like patents in
winner was given the exclusive Sybaris, annual culinary/cookery competi-
tions were conducted and the
Encouragement was given to all those who discover a new rights to prepare the dish for the entire year.
discovery was secured to the inventor for the whole luxury item and the profit arising from such
the world which year. UK however has
can be traced back to the 15th longest tradition of patent in
century. Patents in England were
Letters Patent', which were
issued by the sovereign to granted in the form of
ents. An
example of such first letter patent is the patent inventors who petitioned and acquired the pat-
Utynam in 1449 for developing a method of granted by Henry VI to one Flemish-born
of Eton making
College. The term of the patent was 20 years. stained glass, which was required for the John of
In
windows
France, King Henry
fication in the year 1555. Theintroduced
II the concept of publishing the invention with
patents its complete
the modern
were
granted by monarchy and the speci
patent system was created in 1791.
tion since the inventor's Earlier, the patents were parliament of Paris. Gradually,
right was considered to be
natural
granted without the examina-
and
patent laws in 1844, 1860, 1902 and further on.original one. Further, several revisions
were made to the
The
Australia' is the Australian Australian system of granting the
patent is based on the British laws. 'IP
administering patents. government agency responsible for
However, in United States, Samuel Winslow of North
1641for a new process of making salt. The I836 United America was the first one to get the
patent law. It required the examination States Patent Act was patent in
of the all arguably the first
applications by the goverFment patent office modern
for the
 22IPR. Biosafen and Biocthics
and
this law did not discriminate between US
Search of novelty and usefulness in them. Although.
or the extent of rights granted yet the foreign ap-
toreign inventors with respect to the examination
plicants had to pay much higher fees.
Some Eunopean countries managed without a patent law till much of the 19th century. Switzerland
had a patent system only from 1799 to 1802, not re-establishing it until 1888. Netherlands prohibited
that experienced Industrial Revolution during 19th cen-
patents from 1869 until 1912. Most countries
became clear that patent system stimulated the development and
tury had patent systems. It very likely
dispersal of new technologies, which in turn established the foundation of rapid industrial development.

HISTORY OF INDIAN PATENT SYSTEM

The first patent law in India was passed about 146 years back. which received the assent ofthe Governor
General (GG) on 28 February 1856, one year before the first war of Indian independence in 1857. The
concept of ovelty and the grounds for revocation under the patent law has remained unchanged since
1856. The provisions which were not found in the lndian Patent Act 1970 are as follows:

a The term of patent could not be extended by Govemor General (GG).

a The importers were also treated as an inventor subject to know-how and practices within a speci
fied period.
a There was no provision for provisional specification.
aInventions used by the inventor were not considered to be for public use.
The patent system of India is designed in such a way that it encourages technological innovation by
granting for a limited period of time the monopoly rights to the inventor for disclosing their invention
which is beneficial to the mankind.
The first law in India related to patents was the Act VI of 1856. The objective of this legislation was
to encourage new and useful inventions and to induce inventors to disclose secret of their inventions.
The Act was subsequently repealed by Act IX of 1857 since, it had been enacted without the approval
of the sovereign.
Fresh law for granting "exclusive privileges' was introduced in the Act XV of 1859.
in 1872, the Act of 1859 was consolidated to provide protection relating to designs. It was renamed
as The Patterns and Designs Protection Act under Act XIll of 1872

The Act of 1872 was further amended in 1883 to introduce a provision to protect novelty of the
invention.
In 1888. new legislation was introduced to consolidate and amend the law relating to invention and
designs in conformity with the amendments made in the UK law
The Indian Patents and Designs Act 1911 replaced all the previous Acts. For the first tinme, this Act
brought patent administration under the management of Controller of Patents. The Act was further
amended in 1920 to enter into mutual arrangements with UK and other countries tor securing
priority.
Provisions were made relating to the grant of secret patents, patent of addition, use of invention by
government, powers of the Controller to rectify register of patent and increase of term of the patent.
In 1945. an amendment was made to provide for the filing of provisional specification and submis-
sion of complete specificaticn within 9 months.
In 1949, the Government of lndia constituted a committee under the Chairmanship of Justice
(Dr.) Bakshi Tek Chand, a retired Judge of Lahore High Court, to review the patent rules and regula-
tions in India in order to ensure the implementation of the patent system in the interest of the nation.
 History and Evolution of Patent Law 23
C
Co
etween US and n e Committee submitted its interim renort on 4 August 1949 with recommendations for preven-
the foreign ap- ton of misuse of patent right in India and suggested amendments. The committee also observed
that the Patents Act should contain clear indication to ensure that food and medicine and surgical
ry. Switzerland and curative devices are made available to the Dublic at the cheapest price, which should be made

ands prohibited proportionate with the reasonable compensation to

the patentee.
during 19 cen- Based on the above recommendation of the Committee, the 1911 Act was amended in 1950 in re-
evelopment and 1ationto working of inventions and compulsory license/revocation. Other proviSions were relatedi
al development. endorsement of the patent with the words license of right' on an application by the Goverm-
ment so that the Controller could
grant licenses.
I n 1952 (Act LXX of 1952) an amendment was made to provide compulsory license in relation
to patents in respect of food and medicines, insecticide, germicide or fungicide and a process for

:of the Governor producing substance

I n 1957, the
any invention relating to surgical or curative devices.
or

nce in 1857. The Government of India appointed Justice N. Rajagopala Ayyangar Committee to suggesi
unchanged since necessary changes in the patent law. The report was submitted in September 1959 by the Commit-
WS: tee, which comprised of two parts. The first part dealt with general aspects of the Patent Law along
with evils of the patent system and solution with recommendations in regards to the law and the
second part gave detailed note on several clauses ofthe lapsed bills 1953. This report recommend-
s within a speci ed major changes in the law, which formed the basis of the introduction of the Patent Bill 1965.
a
This amended bill introduced in the Lok Sabha 21 September 1965, which, however
was on
lapsed. In 1967, an amended bill was introduced, which was referred to a Joint Parliamentary
Committee and on the final recommendation ofthe Committee, the Patents Act 1970 was passecd.
O This Patent Act 1970 replaced the 1911 Act so far as the patents law was concerned. However, the
cal innovation by
Act 1911 was continued to be applicable to designs. Most ofthe provisions of the 1970 Act were
1g their invention
brought into force on 20 April 1972 with the publication of the Patents Rules, 1972.
The Patents Act 1970 remained in force for about 24 years without any change till December
us legislation was
1994 with further amendments in 1999, 2002, 2005 and 2006.
f their inventions.
hout the approval A brief history of the Indian patent acts is shown in the Table 2.1.

59. Indian Patent Act 1970

IS. It was renamed
The salient features of the Patents Act 1970, which was in force for 24 years are as follows:
ect noveliy of the
1. The law elaborated the definition of "invention" to mean any new and useful
and
(a) Art, process, method or manner ofmanufacture;
invention
g to
(b) Machine, apparatus or other article;
first time, this Act (c) Substance produced by manufacture; and includes any new and useful improvement of any
Ie Act was further of them, and an alleged invention.
r securing priority.
se of mvention by
2. No product patents
was given intended for
for the substances use as food, drugs, medicines or
any product produced by any chemical processes.
rm of the patent.
3. The term ofthe process patent in respect of food, medicine and drug is for 5 years from thc date
ation and submis-
of sealing of patent or 7 years from date of patent, whichever is shorter.
4. The law explained that certain inventions are considered as non-patentable inventions.
nanship of Justice
5. The law required mandatory furnishing ofinformation and undertaking, regarding foreign application.
rules and regula-
rest of the nation.
 Amend
24| IPR, Biosafety and Biocthis First Anen
The Patents,
Patent System
Table 2.1 Histon of Indian An ordinance
ain to operate aftei
Year of Act Patent Law
based on the British patent
law of 1852. Cer consequently r
inventions
of 14 years.
1858 The Act Vi of 1856 on protection
to inventors of
new manufacturers for a period of tively from 1 J
exclusive privileges granted (making, areas of pharm=
called exclusive privileges
modified as Act XW; patent monopolies 14 years from ad such applicatic
so for
The Act VI and authorizing others to do
was
1859 inventions in India
selling and using
of filing specification).
Second Amen
enacted
Protection Act was
The Patents and Designs T hs
ee c o n d as
1872
Act was enacted T

38 of 2002).
Inventions
1883 The Protection of
Act.
The Act was consolidated as the Inventions and Designs 2003 by repi
1888 The salien
enacted
and Designs Act was
1911 The tndian Patents
into force on 20 April 1972 1. Non-p:
1972 The Patents Act (Act 39 of 1970) Ccame
Act 20
1999 came into force on 26 March
1999 The Patents (Amendment) Act, and ca
2003
The Patents (Amendment) Act 2002 came into force from 20 May 2. The te
2002
the da
(Amendment) Act 2005 effective from 1 January 2005
The Patents
2005
factur
of the
any
criteria in case of publication. 3. The
6. There adoption of absolute novelty
was
for opposition to the grant of a patent. to
7. There was an expansion of the grounds communication and
certain categories of prior publication, prior date
8. It illustrated the exemption of
prior use from anticipation. 4. Pro
directions relating to inventions relevant for defence purposes. inf
9. The laws illustrated secrecy
in
of inventions for government purpose, research
or
for the use 5. Pro
10. The law provided provision
struction to pupils. 6. Th
There reduction in the term of process patents regarding the
substances capable of being
11. was 7. In
used as food or as medicine or drugs.
aL
12. There was enlargement of the grounds for revocation of a patent.
an
as grounds for compulsory licences,
13. The law marked the provision for non-working patents 8. 1
licences of right and revocation of patents.
to use an invention for purposes
14. The law included additional powers of the Central government 9
of government including government undertakings.
licence agreements/contract 10
The law had the provision of making restrictive conditions in
as
15.
void for the prevention of abuse of patent rights.
16. The law had the provision for appeal to High Court on certain decisions of the Controler.
11
17. The law had the provision for opening several branches ofthe Patent Office.
18. The patent can be revoked at any point of time in the interest of the public.
 History and Evolution of Patent Law 25
endn Amendments to the Patent Act
1970
First Amendment
The Patents Act 1970 remained in force
of 1852. Certain
for about 24 years without any change
a n c e effecting certain changes inthe Act was issued on 31 December 1994, which ceased
tillDecember 1994
14 years. Operate arter six months. Subsequently, another ordinance was issued in 1999. Inis oranancc was

es (making. cOnsequently replaced by the Patents (Amendment) Act 1999 that was brought into
rorce rerospe
ears from date vely fromi January 1995. The amended Act provided for filing the product patent application in the
areas of
pharmaceuticals drugs and agro chemicals, as such patents were not allowed earlier. However,
such applications were to be examined only after 31 December 1994.

Second Ammendment
he second amendnment
to the 1970 Act was made
38 of 2002). This Act came
through the Patents (Amendment) Act 2002 (Act
into force on 20 May 2003 with the introduction of the new Patent Rules,
2003 by replacing the earlier Patents Rules, 1972.
The salient features of the
Patents (Amendnment) Act 2002 were as follows:
.
Non-patentable inventions were further codified. Section 2()G) of Patent
Act 2002 defines the term (Amendment)
"invention' as 'a new product or process involving an inventive step
and capable of industrial
application' where inventive step' means a unique feature.
2. The term of
patent was extended to 20 years for all technologies. This term is calculated from
the date of
filing of the application. Earlier, the term of patent for method or of manu-
process
facture of substance (e.g. food, medicines, drugs etc.) was 5 years from the date of the
of the patent, 7 years from the date of
or
sealing
patent, whichever period is shorter and in respect of
any other invention, 14 years from the date of the patent.
3. The date of
every patent will be the date of filing the application for patent. While,
to The Patent Act
1970, the date of patent was the date of filing of according
nmunication and
date of patent is very complete specification. This
important in order to determine the term of parent.
4. Provisions were made for reversal of
Ice purposes. burden of proof on the defendant, in case of
infringement. process patenis
e, research or in-
5. Provisions were made to issue
compulsory licences in order to meet public health.
6. The provision of licence of right was deleted.
capable of being
7. Introduction of
system of deferred examination. This means the Controller will not
amination of the application. Examination of an initiate ex-
application will now be taken up
only upon re-
pulsory licences,
quest by applicant. The request is to be made within 48 months from the
8. It emphasized on application filing date.
mandatory publication of applications
after 18 months from the date of
ation for purposes
the application. filing
9. It included the
provision for process patent for micro-organisms.
ments/contract as 10. Appellate Board was established. This Appellate Board hears and decides
sion of the Controller. This board is above the appeals of the deci-
Controller in hierarchy and the
e Controller.
the Appeal Board is in Chennai. headquarters of
11. The time for filing the request for restoration
from I year to 18 months.
of the lapsed patent (Section 60) was extended
26 IPR, Biosafety and Biocthics Tabl-
l o w e s t i n t e r n a t i o n a l

** ncorporated the provision for parallel import of patented products at lowest inte S. N
of patented commodity from anywhere in
the w
worla
is the import
prices. Parallel import here. A parallel import is a mechanism
that nelpo
*

t 1s cheaper, even though it is patented

price control.
13. Provision was made for exemption from infringement proceedings for use of a patenlea i
tion for obtaining regulatory approval for a product based on that patented invention.
14. It included the provision to protect biodiversity and traditional knowledge.

Third Amendment
The third amendment to the Patents Act 1970 was introduced through the Patents (Amendment)
Ordinance, 2004 on January 2005. This ordinance was later replaced by the Patents (Amendmen)
Act 2005 on 4 April 2005, which was brought into force from 1 January 2005.
The salient features of the Patents (Amendment) Act 2005 amendment were as follows:

1. It extended the product patents to all the fields of technology including food, drugs, chemicals
and micro-organisms.
2. The provisions relating to exclusive marketing rights (EMRs) were deleted.
3. Introduction of a provision for enabling grant of compulsory licence for export of medicines to
countries which have insufficient or no manufacturing capacity to meet emergent public health
situations.
6
4. It had modification in the provisions relating to opposition procedures having both pre-grant and
post-grant opposition in the Patent Office.
5. Strengthening the provisions relating to national security to guard against patenting abroad of
dual use technologies.
6. Rationalization of provisions relating to timelines with a view to introducing flexibility and
reducing the processing time for patent application.

The Patent(Amendment) Rules, 2006, with a view to ensuring time-bound disposal of

plications, has prescribed definitive time frames for various activities by the Patent Offices. patent ap- Cha
A patent application now has to be referred to an
Examiner within 1 month of a request for its
examination. Further, the Controller will now be
required to take a decision on the report of the Ex
aminer within I month of its submission and the First
Examination Report has also to be issued within
6 months of the date of
request for examination of a patent application. The time for granting
sion to file patents abroad has also been permis-
reduced from 3 months to just 21 days.
Patent applications are now to be
tory period of 18 months and, in case of
compulsorily published within 1 month after expiry of the statu-
request for an publication, the application is to be
published within I month from the date of request. This earlywill introduce an element of certainty
step
regarding the date of publication, which was
previously available. Further, the timelines available
not
INT
for applicants and the
public have also been extended in the following manner: Ind
Making a request for examination has been extended from 36 to 48 months. tion
a Filing a
pre-grant opposition extended from 3 to 6 months. resp
Filing reply to pre-grant opposition extended from 1 to 3 months.
a Meeting the
requirements of the First Examination Report increased from 6 to 12 months.
able 2. History and
Evolution of Patent Law 27

Table 2.2 Nes

Before and After the 2006 Amendment to Indian Patent Act
1970
international

e world where S. No. Rules Before Amendment Rules After Amendment

a that helps in to the

Controller refers the application to the Controller refers the application
date of
Examiner Examiner within 1 month from
atented inven-
publication or 1 month from request for
tion examination whichever is later.

2 Request for examination to be made within Request for examination to be made within
36 months 48 months from date of priority or from date of
from date of priority or from date
(Amendment) of fting application filing application.
s (Amendment) 3 The first examination report has to be worked The first examination report has to be worked
out within 6 months from the date of issue of out within 12 months from the date of issue of
ows: the report the report.

rugs, chemicals A A pre-grant opposition to be filed within A pre-grant opposition to be filed within
3 months from the date of publication for the 6 months from the date of publication of the
application or before the grant of patent. application or before the grant of patent.

of medicines to Reply to pre-grant opposition to be filed within Reply to pre-grant opposition to be filed within
ent public health 1 month from date of notice of opposition. 3 months from date of notice of opposition.

th pre-grant and
6
official fees to be paid in ash or bank draft or official fees can also be paid electronically.
cheque.
3 months were required by the controller to
enting abroad of 21 days were required by the controller to grant
grant the permission for filing the patent the permission for filing the patent abroad
abroad from the date of request. from the date of request.
ig flexibility and

sal of patent ap- Changes have also been made to make the patent rules
user-friendly.
Dfices. 1. The
i

request for its

a
working of the Patent Offices has also been decentralized completely. All patent activities
can now be carried on by all the
patent offices (Delhi, Mumbai, Kolkata and Chennai). Earlier,
report of the Ex- certain patent activities could be carried out only by the Head Office
o be issued within Office at (Patent Kolkata).
2. Fees to the Patent Office can now be paid electronically.
granting permis-
Table 2.2 shows the rules before and after this amendment.
xpiry of the statu-

plication is to be
ement of certainty
imelines available
INTERNATIONALCONVENTIONS AND TREATIES
India is a member of World Intellectual Property Organization (WIPO), an international organiza-
tion responsible for the promotion and protection of intellectual property throughout the world. With
respect to patents, India is a member of several international
organizations and treaties as follows:
World Intellectual Property Organization (WIPO)
a World Trade Organization (WTO) with efect from 1 January 1995
12 months. a Paris Convention (for the protection of industrial property) with effect from 7 December1998
28
IPR, Biosafety and BioethiCs
Pat
t Cooperation Treaty (PCT) with effect from 7 December 1998

Budapest Treaty with effect from 17 December 2001.

World Intellectual Property Organization

he World Intellectual Property Organization (WIPO) is a specialized agency of the United Nauo
which is dedicated to ensuring that the rights of creators and owners of intellectual property arc p
tected worldwide. It is of the view that the inventors and authors should be rewarded for their ingen
the legal anu
ity. It is responsible
for the administration of various multilateral treaties dealing with
administrative aspects of intellectual property.
The roots ofthis organization can be traced back to 1833 with the birth of Paris Convention for the
protection of industrial property. It was the first major international treaty formed to help the inventors
of one country to obtain protection in other countries for their creation or invention. The Paris Conven-
tion was signed in 1883 for the first time by only 11 countries and entered into force in 1834. It set up
the basie standards for the protection of intellectual property rights. The convention allows the grant-
ing of the patent for the innovation in technology including biotechnology, trade promotion among
the member countries and protection of industrial property, which includes industrial patents, utility
models, industrial designs, trademarks, indications of source of appellations of origin and repression
of unfair competition. The patents underthe convention included different types of industrial patents
Suchas patents of importation, patents of improvement, patent of addition, etc., wihich is recognized
by the laws of member countries.
The important features of the convention are as follows:

National treatment
a Parallel importation
Right of priority
Independence of patents
Protection against false indication and unfair competition.
However, the main objective of the convention is to give protection for obtaining, maintaining and
enforcing the industrial property of the member nations. The member nations of the Paris Convention
have the advantages that they alone can be the members-of various
international conventions and trea-
ties such as the following:
O Patent Cooperation Treaty (PCT for centralized international application procedure for grant of
patent at national as well as regional level)
Budapest Treaty (Deposit treaty)
oUPOV (Union for Protection of New Varieties of
Plants)
Madrid Agreement (for repression of false or
deceptive indications of source on goods)
Madrid Protocol (regarding registration
of marks)
Hague Agreement (concerning deposit of industrial designs).
In
1886, copyright entered the international arena, with Berne Convention the protection of
literary and artistic works. Like the Paris Convention, the Berne Convention setforup an international
bureau to carry out administrative tasks.
In 1893,
these two small bureaus united to form an international organization called the United
International Bureaux (BIPRI, French
acronym) for the protection of intellectual property with a
 af of s History and Evolution of
Patent Law 29

n, memb Sta
T04
Or seven people, which was the oredccessor of WIPO.
member states, i.e. over 90% of the countries of the world are
1ater on, undergoing structural and adiaistrative reforms. In 1974,
Today WIPO is
its members.
a dynamic entity
B l R I Decame
WIPO became a specialized
with
WIPO

4gny the United Nations system of organization with a view to administer intellectual property
matters recognized by the member states of the United Nations and expended its role. Through its
United Nations member state and secretariat, WIPO seeks to
roperty are pro-
or their ingenu- provide services for international application for industri. property rights,
th the legal and exchange intellectual property information among member countries,
and
provide legal and technical assistance to developing and other countries
nvention for the resolve the private disputes on intellectual property and harmonizes theintellectual property (IP)
lp the inventors laws and procedures.
e Paris Conven- WIPO was established by the convention of 14 July 1967, which entered into force in 1970. Since
n 1834. It set up 1974, it has been a specialized agency administering a number ofinternational unions or treatiesin
llows the grant- the area of intellectual property like Paris and Berne Conventions.
omotion among WIPO undertakes development cooperation for developing countries through advicé, training and
I patents, utility furnishing of documents. A similar agreement on cooperation between WIPO and WTO came into
1 and repression force on 1 January 1996. The agreement provides cooperation in the following areas
dustrial patents
ch is recognized Technical knowledge
Notification of and access to national laws and regulation
Translation of national laws
Implementation of procedures for the protection of national emblems.
The agreement between WIPO and WTO was concluded in December 1995. It provides assis-
tance for legal and technical matters to the developing countries related to TRIPs agreement. Till
date more than 134 countries have received its advice. WIPO's advice takes into account different
situations in every country, given that member states have diferent legal systems and different
political and cultural structures. In order to strengthen the TRIPs implementation process, during
maintaining and the last four years, WIPO has promoted the interaction among different stakeholders at the nationa
aris Convention level to include, for example, officials of law reform commissions, chambers of commerce and fed-
entions and trea- eration of industries, research and development institutions, parliamentarians, high-level officials
of ministers of trade, agriculture, health, science and technology, culture, justice, environment and
dure for grant of others.

World Trade Organization

World Trade Organization (WTO) is the successor organization to the General Agreement on Tariffs
goods) and Trade (GATT). GATTwas signed im 1947, and came into force ont January T948 signed by
23 states. It was amemded in 1966 and lasted until 1993, when it was replaced bythe WTO in 1995.It
was required afterthe WorldWar II torevitalize the world tradeand encourage the countriesto partici-
the protection of pate freely. It is one oftheimportant agencies ofthe United Nations, which providesbetter and wider
an international protection for the private patentholders of the developed nations than the Paris Convention.
GATT was the outcome of the failure of negotiating governments tocreate the International
called the United Trade Organization (1TO). It is a mulilateral agreementregulating trade among about 150 countries.
property with a In its introductory section, the purpose of the GATT was explained as the substantial reduction
of tariffs and other trade barriers and the elimination of preferences, on a reciprocaland mutually
 an
mb
History and
Evolution of Patent Law31

beralize world and liberalize international trade, and

officially commereed onl Jan-
eas to supervise 157
993 ganization dealt with trade regulation among the member countries. Ithad
ng
to expand the
s (HI 2012) of which tt7 are develoningcountries. The headquarters of WiO ISat Geneva.
700 staft, led by the WIO Director
property, textile
d. S activities are supported by a sccretariat of some and are
fWTO, through nere are three oflicial languages of WTO: English, French Spanish. DeciSIOns gen-
C more than 97% of the worid popula-
s
y.The round ex- eraNy Taken by consensus ofthe entire membership representing which meets roughly once in every
Oximately 40%) rOn. Ihe highest institutional body is the Ministerial Conference, and heads
consists of ambassadors of
from developing O years. Bclow this is the General Council, which normally are also included, which
capitals
developed nation delcgationn Geneva, but sometimes officials sent from members Council acts
The General Trade Policy Re-
as
negotiations and eets several times a year in the Geneva headquarters.
tion of industrial view Body and the Dispute Settlement Body. Council report to the Gen-
The Goods Council. Services Council and Intellectual Property (TRIPs)
which deal
eral Council. There are other specialized committees, working groups and work1ng parties
With the individual agreements and other areas such as the environment, development, membership
the participation applications and regional trade agreements.
l tariffs covering WTO'S principal rule book for trade in goods is GATT. It includes some 30,000 pages consisting
of about 30 agreements and separate commitments (called schedules) made by individual members
in specific areas such as lower customs duty rates and services market-opening. Through these agree-
participated and
ments, WTO members operate a non-discriminatory trading system that spells out their rights and

r 8 months, with
their obligations. Each country receives guarantees thatits exports will be treated fairly and consis-
tently in othercountries' markets.SumeTutesapply for theimports intOitS market.The system also
Scovering a new
gives developing countries some flexibility inimplementingtheircommitments.
WTO has several benefits like the system helps in promoting
peace, helps in dispute settlement,
the participation
makes rules that make life easier for all, conducts freer trade that cuts the costs of living,provides
are shielded from
during 1960-62.
more chorce of products andqualities, incomethatis due israisedand governments
of state, Douglas
lobbying. Moreover, the system encourages good government.
in it, resulting in
More specifically,its main objective is to help trade fHow smoothly, freely, fairlyand predictably
at the internationallevel. Internationaltrade is beneficialtoallthecountries and their citizens. It isa
to the creation of factthat trade leads to growth, which in turn promotes national development and reduces poverty. The

7. With 62 coun-
foowingare its activities:
o Negotiation to reduce or eradicate hindrances in trade («.g. import tariffs and other barriers to
orld trade. It also
sed in the context trade) and agreeing on rules that govern the conduct of internal trade (anti-dumping. subsidies,
ther country t a product standards etc.)
nnot be explained o Administrating and monitoring the application of WTO trade agreement rules in goods, trade in
than 'fair value' services, IPR
It causes or threat- Reviewing the trade-related policies of WTO members as well as ensuring transparency in re-
gional and bilateral trade agreement
with the participa- o Settling disputes among its members regarding interpretation and application of the trade agreement
and 'framework g Educating public about WTO, its mission and its activities
illion. Conducting economicresearch
under WTO: Assisting the accession (process ofbecoming a member) of some 20 non-member countries
Building capacity of developing country government officials in international trade matters
Assisting developing countries in trade policy issues, through technical assistance and training
programmes
32
IPR Biosafety and Bioethics
IPR,

Cooperating with other international organization

Provising detailed information on biotechnology, genetically modified (GM) food, and their
business
Deaiing wiu the cthical iesmes in business
Helping in smooth and easy conduction of trade at international levels.

WTO Treaties
The following treaties are enforced by the WT0:
General Agreement on Tariffs and Trade (GATT)
General Agreement on Trade and Services (GATS)
Agreement on Technical Barriers to Trade (TBT)
Agreement on Government Procurement (AGP)
Agreement on the Application of Sanitary and Phytosanitary Measures (SPS)
9Agreement on Trade-Related Aspects of Intellectual Property Rights (TRIPS)
O Agreement on Trade-Related Investment Measures STRIMs)
Agreement on Agriculture (A0A)
Doha Round
In November 2001, divergences between developing and
the declaration on the TRIPs Agreement and developed countries led to acompromise on
round of trade public
health. It was the Doha Round, which is the latest
negotiations among WTO members in which 142 countries participated and the aim
the
of the round is to achieve
major reform of the international trading system through the introduction
of lower trade barriers and revised trade rules. This was the joint effort of India, Brazil and 55 African
countries and all the 142 countries
measures in order to
supported the view that governments are free
to take all necessary
protect the public health. WTO accepted the view that patents should not hinder
the public health
protection. Public health WTO's priority;, this was a boon to India. It covered about
21 areas of trade. The round is also known
fundamental objective was to improve the
semi-officially as the Doha Development Agenda as its
areas were covered in the round:
trading prospects of developing countries. The following
1.
Implementation-related issues and concerns
2. Agriculture
3. Services
4. Market access (for non-agriculture products)
5. Intellectual property: trade-related aspects . .

6. Relationship between trade and investment

7/Interaction between trade and competition policy pr
8. tin
Transparency ii'government procurement.
de
9. Trade facilitation
de
10. Anti-dumping
11. Subsidies
12. Regional trade agreements
 I3. History and Evelution of Patent Law| 33

615. E
13. Dispute settlement
d and their
4Trade and environment

Sma 5. E-commerce

tad Trad
16. Small economies

ade 17. Trade, debt and finance

8. Trade and technology transfer
19. Technical cooperation
20. Least-developed countries (LDCs)
21. Special and difterential treatment for developing countries
and deci-
Doha declaration comprises of thedeclaration on TRIPs Agreement and public health,
timetables for current
sion on implementation-related iss es and concerns, includes elaboration of the
other issues.
negotiations on agriculture, and services or negotiations related to

The TRIPS Agreement

which was es-
WIPO already existed before the establishment of the WTO or the Paris Convention,
and the Berne
tablished for the protection of industrial property (e.g. patents, industrial designs etc.)
and artistic works (i.e. copyright). But
Convention, which was established for the protection of literary
ompromise on or had inadequate protection standards. There-
Some areas were either not covered by these conventions
ich is the latest number of new or higher standards.
fore, TRIPs agreement came into being, which added significant
ed and the aim The TRIPS Agreement, which came into effect on 1 January 1995 is to date the most comprehen-
e introduction intellectual property. It provides standards for the full range of intel-
sive multilateral agreement on
and 55 African lectual property rights and also the enforcement of those standards both internally and through legal
e all necessary and administrative actions.
uld not hinder The areas of intellectual property covered are as follows:
covered about
Agenda as its O Copyright and related rights (i.e. the rights of performers, producers of sound recordings and
The following broadcasting organizations)
Trademarks including service marks
o Geographical indications including appellations of origin
Industrial designs
a Patents including the protection of new varieties of plants
a Layout designs of integrated circuits
o Undisclosed information including trade secrets and test data.

The TRIPs agreement extended its protection scope to such technological areas as pharmaceutica
products and computer software, which were previously unprotected in many countries. The gener
t

year for industrialized 5

timetable for implementing the TRIPs agreement isI countries,
years
for lea
developing countries and countries shifting from centirally plánnëd economies, ànd 10 years
developed countries.
The agreement covers five broad issues:

a Application of basic principles of the trading system and other international intellectual prop
agreements.
a Methods used for the adequate protection of intellectual property rights.
 34 IPR, Biosafety and Bioethics

Enforcement of those rights sufficiently and adequately in their own territories.

Settling of disputes on intellectual property rights between members of the wio.
pecial transitional arrangements during the period when the new system is being introduced.
The TRIPS agreement has three basic features such the
as
following.
.Standards: In respect of each of the main areas of
intellectual property covered by the TRIPs
Agreement, the Agreement sets out the minimum standards of protection that has to be provided
by each member country. Each of the
main elements of protection is defined,
matter to be
protected, the rights to be conferred and namely the subject
the minimum duration permissible exceptions to those rights, and
of protection. It allows countries to
that regulations must be set their own standards, but it also
based on science. says
protect human, animal or plant life or health. They should be applied only to the extent
necessary to
And they should not
identical or similar conditions arbitrarily unjustifiably
criminate between countries where or dis-
encouraged to use international standards, guidelines and prevail. Member countries are
probability to be challenged legally in a WTO
recommendations and if they do so, the
sures which result in dispute decreases. However, members may use mea-
higher standards if there is scientific
countries to use different
standards and different methods of justification. The agreement still allows
health protection level of inspecting products. If the measure of
the
an
exporting
importing country is expected to country is
equivalent to that of the TE
The main TRIPs accept the exporting country's standards importing country, then
standards, and methods. The
patent law are as follows: relating to
pharmaceuticals, that countries must lect
include in their
for
Availability of patents for both
involve an inventive pharmaceutical
step (i.e. non-obvious) and products and processes
inventions that are new,
o Protection
of the
product
are
capable of industrial
application (or useful)
Availability of proceduresdirectly obtained using
at national level patented
a
process
against infringement. to enable patent owners to
protect their rights
In addition, if
exceptions to patent rights and
islation, they should be, respectively, limited andcompulsory licences are
2. conditional to conform incorporated in
to the TRIPs patent leg-
Enforcement: It is important to have Agreement.
they have to be enforced. intellectual
This second feature property laws but mere laws are
for the deals with the
enforcement of intellectual internal not
enough,
principles applicable to all IPR property rights. The Agreement methods or
civil and enforcement procedures. In lays down certain procedures
administrative addition, general
right holders canprocedures and remedies, provisional
so that it contains
tough enough to discourageeffectively enforce their rights. The measures, criminal procedures
provisions on

equitable, and not unnecessarily others from

further violations. Thepenalties for infringement are Maja
enforcement should be complicated or costly. The agreement procedures must be fair and
handled,
injunctions, damages and other including rules for describes in detail Before
conditions, to order the penalties. It
obtaining evidence, provisional how werer
says courts should measures,
disposal or destruction of have the
right, under no inte
3.
Dispute settlement: The pirated or counterfeit goods. certain depenc
obligations subject to the Agreement makes disputes between WTO members in protect
indicates the subjects of WTO's dispute settlement
issue, each dispute can WTO disputes. Because there procedures. There is a long respect
list of ofTRIPs
tions ir
are often a number issues produc
'under goods, intellectualappear under more than one heading. The issues ofareways to describethat able, us
property and services. broadly an
classified local ca
now cor
sible to
 History and Evolution of Patent Law 35

The obligations under the agreement apply equally to all member countries, but developing
countries will have a longer period to face them. Special transition arrangements operate in the
situation where a developing country does not presently provide product patent protection in
gintroduced.
the area of pharmaceuticals.
Patents are very important regarding drugs and pharmaceutical industry. The reasons for the impor-
d by the TRIPs
tance of patents in the pharmaceutical industry are as follows:
Is to be provided
mely the subject The costs of pharmaceutical R&D are high.
those rights, and There is a disclosure requirement, at the time ofregistration.
s, but it also says Imitation in this area is relatively easy; therefore, the patent is essential to protect the original
tent necessary to invention.
unjustifiably dis- Phamaceutical patents allow the company to make extra profits due to the monopoly rights which
ber countries are the patent confers. The company can charge a higher price and earn more than would have been
if they do so, the possible in case of free competition.
rs may uSe mea- From these profits, R&D costs
mant still allows
can be recovered.
lt the measure of TRIPs Principles
ingrountry, then The TRIPs
i met
ods. Agreement has a major role to play in harmonization of the norms and standards of intel-
tin lectual property protection. It requires members to comply with a defined set of minimum standards
lude in their
for the protection of intellectual
property rights covered in it.
Its basic principles are as follows:
ons that are new,
a It makes it compulsory for the member countries to provide patents for products and processes in
cation (or useful)
all fields of
technology, subject to the tests of novelty, inventiveness and industrial use.
I t mandates patenting
otect their rights of 'micro-organisms', and microbiological and non-biological
processes.
The members are
allowed to make only limited exclusions from patentability. The exclusions are
allowed on the grounds of public order or morality, or
inrespect protection extended to human,
of
ated in patent leg- animal and plant life or health.
RIPs Agreement. a It also gives option to the states for protecting new plant varieties through patents or
effective sui generis system. , through the
are not enough,
a It ensures that the
ds or procedures protection and enforcement of intellectual property rights should contribute
to the promotion of
n certain general technological innovation for the mutual advantage of producers and users of
ins provisions on technological knowledge and in a manner conducive to social and economic welfare.
inal procedures,
Major Changes in Indian Patent System Post-TRIPs
infringement are
must be fair and Before the TRIPs Agreement, pharmaceutical patents and other intellectual property rights on drugs
Des in detail how were not
recognized in many developing countries (unlike many industrial countries). There were
no international standards for
sional measures, patent protection; countries had varied regulations on IP
ht, under certain depending on their own needs. In the pharmaceutical sector, some 40 countries did not protection
protection for phärimaceutical pröducts. Patents were simply not available for provide patent
tions in these countries, which pharmaceutical inven-
implied that no one could claim an intellectual property right on such
respect of TRIPs products. As a result, copies of medicines protected by a patent in other countries were
list of issues that able, usually at a lower price than the original patented widely avail-
ays to describe an local companies or imported, without
drug. The copies were either manufactured
by
having to ask the patent holders' permission. This practice has
oroadly classified now come to an end.
Copies of patented drugs will remain on the market but it will no
sible to manufacture and market copies of new patented medicines in those longer be pos-
40 countries, unless the
36 IPR, Biosafety and Biocthics
Table 2.3 Patent Laws Post-TRIPs
Agreement
Changes in lndian
Patent Amendment Act
S. No. Indian Patent Act 1970 TRIPs Agreement

Process and well as

Full implementation of TRIPS
ny process patent was grant- Included agreement 2005 (Patent Bill
ed (not the product patent) in Product patent in all fields of of
TRIPS

food, chemicals and medicines technology

2005) onth a t e nB
t ill

or drugs years
Conforms to TRIPS requirement
2 Term of patent: 14 years; in
case of chemicals and drugs,
Term of patent: 20 years
(Patent Act 1999) patem
5 to 7 years patent Ca
3 Limited compulsory licensing, Conforms to TRIPS requirement tional apy
Compulsory licensing and signed on
licensing of drugs no ficense of right was furthe
4 Several areas were excluded Almost all fields of technology Uses the exceptions allowed by The trea
TRIPS. Rejects the patents on
from patents like the method are patentable. Plant varieties countries
of agriculture, surgical or ther- and some areas of agricul living things, non-living sub- Internatio
stances ocCurring in nature,
apeutic methods of treating ture and biotechnology are
plants and animals
major incri
humans, animals or plants in excluded from patentability
order to increase the economic internat
PCT.PsA
value of products pe
office is t
Government allowed to use Very limited scope for Conforms to TRIPS requirement entitled to f
patented invention to prevent governments to use patented for US appl
Scarcity inventions an internati-
An India

1. He ca
original manufacturer has chosen not to seek any patent protection there. Table 2.3 differentiates the
changes in the patent law after the introduction of TRIPs in 1995. filing
Under the TRIPs Agreement, all WTO members are required to make patents available for phar- filing
maceutical and biological inventions in their countries. Article 27.3(b) of TRIPs Agreement gives Paten
its members some freedom to exclude plants, animals and 'essentially biological processes from from
patentability as genetically modified organisms and GM foods had created fears and uncertainty of its 39 frc
impact on health and the environment and have raised important ethical issues in diferent countries. 2. The a
However, it also states that micro-organisms and non-biological and micro-biological processes have missi
to be patentable. The wording is deliberately ambiguous, in order to give countries some freedom to filed
interpret this in their national legislation as they consider fit. Indiar
The TRIPs Agreement requires the WTO member states to introduce patent protection only to the da
products that were invented after 1 January 1995, i.e. products for which a patent application has been
The pate
filed in a WTO member state after 1995. This means that, in accordance with TRIPs, products already
on the market cannot be given patent protection, because if they are already marketed, they are not
internationa
is carried ou
new, and so do not meet the TRIPs conditions necessary to grant a patent. Therefore, only new drugs
or new indications, formulations or processes invented after 1995 are patentable in all WTO member SearchingA
by the ISA
countries, or before a year, if priority is claimed. ing the pate
The developing and least-developed countries not granting drug patents must have a system, often
referred to as a 'mail-box' system, to store patent applications as from 1995 until the transitional pe is based on

riod expires. At this time, the various patent applications waiting in the 'mail-box' will be examined Internationa.
which starts from the filing date, will Paris Co
according to the TRIPs standards and, if granted, the patent term, members. P
 last fo
ronpeembe
History and Evolution of
last for 20 years. 1The
Patent Law 37
member countries have to meet some
member countries may minimum standards; however,
go for
Act Europe and the United
States,
greater IP protection than required in the Agreement. For
some WTO
example,
5 years, to pharmaceutical patents
may be extended beyond 20 years,
in
on of TRIPs compensate for the long delays
in obtaining marketing for up to
atent Bil extensions vary from country to approval for a drug. Such patent
country since there is absence of international
on the date of
marketing approval. However, the standards, depending
pharmaceuticad
patent cannot be extended
approval in European countries, and 14 years in the Unitedbeyond
years from the date of marketing 15
States.
requirement Patent Cooperation Treaty
Patent Cooperation Treaty
(PCT) is administered by WIPO, which gives rise to 'centralized
requirement
tional application
procedure' for the grant of patent at national and regional levels. The interna-
signed on 19 June 1970 at Washington, amended on 28 treaty was
was further modified on 3
September 1979 and on 3 February 1984. It
October 2001.
is allowed by The treaty makes it
possible to seek patent protection for an invention simultaneously in
patents on countries. The total number of PCT many
-living sub contracting states as on 7 September 2012 is 146 (also known as
International Patent Cooperation
in nature, Union). A majority of countries are signatories of the PCT including
major industrialized countries like Argentina and Taiwan.
als PCT application can be filed
by anyone who is a national resident of the contracting state. An
international patent application (PTC
office is the branch of PCT where the
application) is filed at the receiving office (RO). The receiving
patent applications are filed. Nationals and residents of India are
irequirement entitled to file international applications for
patents under PCT at Patent Receiving Office, Delhi while
for US applicants, the branch office is US patent office. Applicant from any contracting state may file
an international patent application at the International Bureau in Geneva.
An Indian applicant can file a PCT international application in the following manner
1. He can file the application in the Indian Patent Office, which acts as the Receiving Office. Afier
erentiates the
filing a patent application-in India, anytime before the expiry of 12 months from the date of
filing, an international application can be filed in International Bureau of WIPO or in Indian
able for phar- Patent Office as Receiving Office. However, if the international filing is done within 6 weeks
eement gives from the date of filing in India, this can be done only after taking the permission under Section
ocesses from 39 from the Indian Patent Office.
ertainty of its 2. The application can also be filed directly in the International Bureau of WIPO after taking per-
ent countries. mission under Section 39 from the Indian Patent Office, claiming the priority of the previously
rocesses have certified copy of the
filed Indian patent application along with the prescribed application fee. A
ne freedom to within 16 months from
Indian patent application may be filed with the international application
the date of priority.
2ction only to
applicant
inventor the desires. In such cases.
application can be withdrawn if the
or
ation has been The patent
PCT makes an international patent search and the search
ducts already international publication will not tak place.
an International
of the major patent offices appointed by the PCT assembly as
1 they are not is carried out by one
written opinion are communicated
Authority (ISÄ). The international search report and the
nly new drugs Searching it helps in the process of fil-
to the applicant. PCT
does not issue the patent directly but
by the ISA examination
WTO member and cost-eflective manner. The
countries in the most efficient of the
ing the patent foreign
in
is made by the most competent people
international search report and
System, often is based on preliminary
Examination Authority. to its
ransitional pe- International Preliminary conventions and treaties exclusively
number of international deposit of
1beexamined Paris Convention opens a conventions apart from Budapest Treaty
(for
members. PCT is one of
the international
iling date, will
38 IPR, Biosafety and BioethicS (for repres-
Madrid Agreement
varieties of plant),
the protection of new Madrid Protocol
(concerning depositof
d 8nism), UPOV (for goods) and
indication ofsource on
Ofalse or decetive disc
industrial design). and
Procedure search report
between4 dise
International Searching
Authority, PCT issues
a

search report, the applicant

posit of
r due verification by the Based on the international
to
ture col
from the date of priority filing. If yes, then it is important
H nths
cCiaes whether it would be
worthwhile to seek
national protection.
and other expanses to enter the national
the sam
Befon
In how many countries because it
includes fee amount
OW international search report. In addition to of any
on the
1n each country. Many patent authorities rely international searches may
d international search, one ormore optional
supplementary ful, tim
Ompulsory the applicant's request. in ever
carried out by participating International
Searching Authority upon
the ap-
do De is published by PCT after 18
months from the priority date of filing order to
he patent application 'International Preliminary Examina-
the PCT for World i
plication. The applicant makes demand or requests to amend the claims. Such applications
remain in
ion. As a result the applicant gets an opportunity ing the
PCT system for another 10 months, which is advantageous to
the applicant. Finally, at the 30h month Gover
comes to an end. In this way,
the
from the filing date of the international application, the role of PCT The
enters the national and regional phase. If
international phase ends and the international application
the entry into national or regional phase is not performed within the prescribed time limit, the interna-
where
nized i
tional application generally ceases to have the effect of a national or regional application.
Treaty.
Salient Features setting
countrie
This system is quite good and efficient only if foreign protection is desired in one or two member
materia
countries but if it is desired in too many countries, the applicant has to bear the huge cost, which
includes separate filing fees and translation cost. Ce
The system provides much longer time for filing the patent application in member countries. The Vo Ge-
time available under Paris Convention for securing priority in other countries is 12 months from O Pur
the date ofinitial filing, whereas under PCT, the time available could be 20 to 31 months. O Nal
o The inventor is also benefitted by the search report as it is the International Search Report The
The main advantage of the PCT procedure or international procedure is the possibility to delay the cent reg
national or regional procedures, and the respective fees and translation costs along with unified filing Till 20
procedure. States a

Budapest Treaty accepta

The treaty for the international recognition of the deposit of
microorganismsfor the purpose of patent
procedures was started at Budapest on 28 April 1977 and amended on 26 September 1980. The treaty PATEN
is administered by the World Intellectual Property
Organization (WIPO) and allows the deposit of mi- Patents:
croorganisms at the International Depositary Authority (IDA) for the purpose of patent procedure. The some ba
important requirement is that the invention should be described in detail to the public and this disclosure a tabular
is normally achieved by means of a written description
supplemented by drawings where necessary.
Usually in order to meet the legal requirement of disclosure, patent application and patents must dis- Patent
close in their description the subject matter of
the invention clear and complete enough to be carried out The Unit
by the person skilled in the art. However, some problems may arise for inventions involving the use of
new microorganisms (i.e. whose information is not available to the public). For example, in case of an United S
organism isolated from soil, can be improved by mutation and further selection, it would be impossible tection o
progress
o des

History and Evolution of

for repres- to describe the strain and its Patent Law39
ng deposit of selection
fromSoil himself. In such a case, the sufficiently to guarantee another person obtaining the same
disclosure. Moreover, if the microorganism can be considered to be an essential strain
microorganism was not generally available to the
and disclosure of the invention
part of the
might be
not public, the written details
port between 4 disclosure of an invention involving the use ofsufficient. This led to the
recommendation that the written
t, the applicant posit of the microorganisms in a
a new
microorganism must be
culture collection/institate like supplemented by the de-
turecollection would then make the recognized
is important to
Before 1970s, there was no
IMTECHrindia.
microorganism available to the publicaccórding to the
The cul-
ter the national
the same
uniform requirement.
system of deposit, or there was no alternative but to
. In addition to microorganism
of any of their
in several
collections in
different countries to guard against the deposit
l searches may applications failing on the possibility
time-consuming and expensive too andgrounds
ful, of
insufficient disclosure. Such
ant's request. aBlso resulted in practice was waste-
of filing the ap- inevery country in which they wished to file applicants depositing the microorganism
order to solve the patent application referring to that
a
inary Examina-
World Intellectual problem
of such
multiple deposits, the UK government microorganism. In
itions remain in Property Organization (WIPO) should
proposed, in 1973, that the
t the 30th month ing the purposes of all the study the possibilities of one
Governing Bodies of WIPO.
deposits that would otherwise be needed. This deposit serv-
In this way, the proposal was adopted by the
The
treaty ensures that an applicant needs not to
gional phase. If
mit, the interna- where he or she want to obtain deposit the biological material in all the
nized institute only and this patent. Deposition of the biological material can be made countries
1on.
deposit will be at one
Treaty. It helped in solving the difficulties recognized in all countries that have signed the recog-
setting up a series of International which may arise in
describing the nature of Budapest
Depository Authorities (IDA) and recognition by all of theinvention by
:or two member countries in a single IDA. The
treaty does not define the member
uge cost, which materials able to be deposited under the Budapest meaning of microorganisms but the
treaty includes the following: range of
a Cells: bacteria, fungi,
r countries. The
Genetic vectors
eukaryotic cell lines, plant spores.
12 months from (plasmids or bacteriophage vectors or
months.
a Purified nucleic acids. viruses) containing a
gene or DNA fragment.
a Naked DNA, RNA or
ch Report. plasmids.
The period of storage of deposited
ility to delay the cent of microorganisms may
request sample, whichever is earlier. It be 30 years or 5
years after the most re-
ith unified filing Till 20 November 2012, there protects microorganisms from loss or
were 78 non-availability.
contracting states to the Budapest Treaty including
States and Australia but now the European Patent Organization the United
acceptance of the Treaty. (EPO) has also formally declared its
urpose of patent
1980. The treaty PATENT LAWS IN OTHER COUNTRIES
he deposit of mi- Patents are granted
country-wise, so there are different patent laws in different
t procedure. The some basic features remain the
same in every
countries. However,
nd this disclosure a tabular form so as country. The laws in various countries are
to get précise information with
reference to US patent laws. explained in
where necessary." ** ''** ****"**' ****** ***.

patents must dis- Patent Laws in Unites States

to be carried out
The United States Patent and Trademark
olving the use of Office (USPTO or Oftice) was
United States within the established as an of the
ple, in case of an Department of Commerce. The role of the agency is to grant patentsageney
for the pro-
tection of inventions and to register trademarks. The
uld be impossible Office promotes the industrial and
progress of the nation through the preservation, classification and technological
dissemination of patent information.
 40| IPR, Biosafety and Bioethies sections entitled
Act of seven
1790 and w e r e short
a
existed since were
confined to citizens ntit

f e d e r a l patent laws have to patents

rights
n t

1793, which was drafted

Progress Useful Arts'. In
of a slightly longer Act, The
t o promote the replaced by also who had been
of
,United States. This small
Act of 1793
was

amended in 1800 to allow foreigners

an oath that
the
197h
But the 1793 Act
was
subject to them making ies, t
m a s Jefferson. obtain patents,
dent in the United
States for two years
to
in the United
States or abroad. Since
the 1870s and The pa
is not a prior knowledge the United States under- Treaty(
vntion in question international organizations
were created,

1880 were a period in which many

basic structure of the present
law was adopted in 1952. filed at y
the
n several amendments
till 2009, though
laws in detail, Table
2.4 differentiates between Indian under th.
have already discussed the Indian patent at the E-
AS We
and US patent laws.
Table 2
Table 2.4 Indian and United States Patent Laws
S. No.
. No. United States Patent Act
Indian Patent Act

Indian patent laws are strict. US patent laws are liberal.

The Indian Patent Act quite elaborately de- US patent laws allows the grant of patent to
scribes the non-patentable inventions under anyone who invents or discovers any new and
Sections 3 and 4 (eg. business model or useful article or machine or process of manufac-
Computer program, isomers of the chemical ture or composition of matter or any new and 2
Compounds, mathematical models etc.) useful improvement in the existing invention
3 Inventions related to the atomic energy are not inventions related to the
atomic energy are
patentable in India widely accepted in United States
4 Inventions that are contrary to the
public order Inventions that are 3
or
morality are not granted patent (e.g. patent design are allowed patentable and novel in
or novel
design of guns etc.) (e.g. patent or novel design
of guns etc.)
Inventions which are mere
components are not grantedarrangements of
patent even if it
Inventions which are arrangements of compo-
nents is
has utility (e.g. swiss
kife assembly granted patent if it has some utility
Indian (e.g. swiss knife assembly)
patent laws grant patent on
basis. Thus, the true
inventor should
"first-to-file' US patent laws
grant patent on 'first-to-invent'
application and challenge his/herfileinvention.
the pat- basis.
ent Therefore
the lab records,
the inventor
should maintain
Indian patent law has
pre-grant and post- proof of dates of invention,
grant opposition. US patent law
has the provision of
Plants are not
patentable in india
opposition only. post-grant
Software is not patentable in India; Plants are
they are
patentable in the united States
copyrightable. software is patentable in the United States
Patent agent should be
Indian
Patent agent from other
The
application for fling the patent starts with practice in United States countries can also
Form no. 2 with all the
documents related The patent document is the m
the invention attached with it
to
abstráct; details of the first sheet with n
invention,
classification no. and important ssignees; ste
12
the inventor has invention. drawing of the tio
published his invention.
before filing the patent, if the inventor has pre
then he
loses all his
rights India.
in automatically will not lose his published his
invention, he int
right to file the patent
year. till one ap
tive
(ex
 History and Evolution of Patent Law41
ctions entitled
ned to citizens Patent Laws in European Countries
up set October
on 7
ch was drafted Patent Organization (EPO) is intergovernmental organization,
an
uropean in Munich in 1973. Ithas two bod-
who had been the basis
of the European Patent Convention (EPC) signed
9Ies, theonEuropean Patent Office and the Administrative Council, which supervise the official activities.
in oath that the
such as the WTO'S TRIPs and the Patent Law
the 1870s and The patent law is shaped by international agreements
and the applications for patents can be
d States under- Treaty (PLT). Presently, 38 states are the members of EPO
international application may be filed
dopted in 1952. fhled at the relevant national patent office or at the EPO while an

nationalized in the desired countries or

between Indian under the Patent Cooperation Treaty (PCT), which can be later
at the EPO. Table 2.5 differentiates between European and US patent laws.

Table 2.5 European and US Patent Laws

S. No. European Patent Act US Patent Act

The first person to have filed the application will The first person to invent will get the patent. This
get the patent. Filing date is important. usually involves examining laboratory logbooks,
establishing dates for prototypes, and so on.
of patent to if the person who filed later is found to have
any new and invented earlier, he may be awarded the patent.
cess of manufac- if the invention has become publicly available in There is a one-year grace period (35 US Code
rany new and 2
any way, by the inventor or anyone else, before Section 102), which means that the inventor can
ng invention freely publish his invention without losing patent
the filing of patent application, the application
energy are will be rejected (Article 54 EPC). rights. This only applies for the United States.
Any one way of practicing the invention must be us patent law requires the inventor to include
and novel in included in the application (Article 83 EPC), but the best way to practice the invention in the
or novel design it is not compulsory to state that this way is the patent application (35 US Code Section 112).
best way, or a good way.
ents of compo
All patent applications are published 18 months Now in the United states, patent applications
after their filing date, unless they have been are published 18 months after their filing date,
some utility
withdrawn. unless they have been withdrawn or they are
filed with a non-publication request, stating ti
'first-to-invent the application is for United states only (Earlier
ould maintain
the patents were published only after grant)
of invention.
The European Patent Convention is a treaty A US patent right is enforceable in the whole
5
1 of post-grant signed by 27 European countries. Patents under territory of the United states. It aliows the
the EPC are granted by the European Patent patent holder to prevent anyone from making.
ited States office (EPO) in Munich. using or selling the patented invention in the
nited States United States as the US patent law (35 US Code)
is a federal statute.
ries can also 6 The two most important patentable require- US requirement that the invention must be
ments in European patent law are that, an novel and must be non-obvious (35 US Code
invention must be novel and involve an inventive Sections 102 and 103)
t sheet with step (Article 52 EPC). It clarifies that the inven-
n, assignees, tion has an inventive step if it solves a technical
it drawing of the problem ina non-obvious way, which further
introduces two extra requirements: it must solve
is invention, he a problem (no problem solved means no inven-
patent till one tive step), and that problem must be technical
excludes solving economicproblems).
(continued)
 42 IPR, Biosafetr and Biocthics Tabtk
S. No.
Table 2.5 (Continued US Patent Act will
patents)
(and
S. No. European Patent Act applications

US p a t e n t one-part claim
have any-
typically where
7 turopean patents and applications
contain two-part claims.
almost always
r e - e x a m i n a t i o n
procedure
to the
the y
(Virtually always) It has a and
evidence

The opposition can be filed within nine months present

reasons

a granted The iv
8 the validity of e n g a g e s
one can

after the grant of a patent; anyone

can file an
USPTO to challenge holder only
Chine
arguments and and
opposition with the EPo, with Here the patent
patent. USPTO Exaine
evidence. The patent holder and the opponent with the
ina discussion
each other. Finally, a deci- reasons anu 3 Chin
n e n aebatewith establish the validity of the
evidences and these proceedings.
s a d e by
the EP0 based on
challenger is
not a part of pate
arguments.
open to
the patenung o impr
Patent Offices, United States is more
Cording
an
to
the European and uK
invention with respect to software is patent software than other
countries.
Soft
able, if it makes a 'technical contribution' over the diag
known art to solve the existing problem. plan
A pa

Patent Laws in China 'neg

China became the member of the WIPO in 1980 and of the Paris Convention for the Protection or Inaus
only
trial Property Rights in 1985. China is also a member of Patent Cooperation Treaty (PCT) Since 19
using
valid
and has ratificd the agreement on TRIPs since 2001. In 1984, China enacted is frst patent law grants make-
ing patents for inventions, utility models and designs with a view to promote development in scence
and technology. However, the law provided little protection to pharmaceutical arnd chemical inventions. Chine
In 1992, China faced amendments to the 1984 Patent Law, in compliance with an agreement between grant
China and the United States, i.e. memorandum of understanding (MOU) with a view to join the W1O. of vali
The 1992 Amendment in the Patent Law resulted in a provision for the protection of pharmaceutical be obe
and/or chemical inventions, and also microbiological products and processes, along with the extension the ex
of patent term to 20 years. The law also promoted and encouraged investment in biotechnology research paten
and development, and increased the importation of chemical or pharmaceutical products to China.
In 2000, the Chinese Patent Law was amended again, which came into force on 1 July 2001.The
Chines
does n
amendments provide patent owners new substantive rights, such as rights of 'ofer for sale', simpli-
decisio
fied patent application procedures and improved administrative and judicial enforcement procedures and re-
Both India and China have similar national laws for 1P, and have signed up to similar international
conventions and treaties; there are differences on basic political, social and economic fronts, which
strengthen their IP regimes.
However, the Chinese laws are difierent from US laws. Although, China is engaged in significant Patent Law
efforts to enact IP protection, it lacks effective enforcement of these laws, which is a long-standing prob- Fukuzawa Yuk
lem. The first reason for this can be education and cultural trends. For centuries, Chinese believe that also regarded
inventions and creativity belong to the society, and should be freely shared or owned by the Chinese gov his 1867 writin
ernment. Therefore, traditional Chinese culture is not ready to accept 1P rights as private rights owned by
experimental p
a particular person; moreover the entire concept of lP protection is quite new for many Chinese and busi- by the Patent N
ness entities. They are not aware of their IP rights and their need to seek protection for an invention; also
Day' by the Mi
many infringers do not know that their activities infringe other's private rights. Many Chinese lawyers and The first se
judges are also new to this field. Therefore, much work has to be done in enforcing and implementing the
Zuisho obtaine
patent protection in China. Table 2.6 diferentiates between Chinese and US patent laws.
 44
44
IPR, Biosafety and Bioethics
atent No.
2, 3 and 4 for Monopoly Act was replaced by the Pat-
cntAct in 188 .. Or tea processing machines.
machines. The
I he Patent
ra

in 1909.ABthePatent Act was replaced by the Patent Law of 1899, which was completeiyrev
Japanese e Meiji era, the Patent Act was completely revised twice, in 1921 and 1959. T hus, the
ings, the was amended several times in 1959, especially regarding the opposition proceed-
O patent, and compliance with the Patent Cooperation Treaty (PCT) in relation the
novelty criteria.
Table 2.7 differentiates
betwecn Japanese and US patent laws.
Table 2.7
Differences between Japanese and US Patent Laws
S. No.
Japanese Patent Law
United States Patent Law
Japan foliows first-to-file system. USfoltow first-to-invent system.
An examination will be carried out
the application only for Applications are examined in the order they
for which the applicant or a were filed, unless the
third party has US Patent Office finds a
fileda request for examination
(within 3 years) and paid the examination compelling reason to do otherwise
fees
3 An
application can consist of more than one A
claim. There is no patent application can have only one claimed
surcharge for multiple de-
pendent claims. However, invention. if the examiner determines
when filing that there
for examination, the
a
request is more than one claimed invention in the ap-
based the number
official fee is calculated plication, he will
on
of claims the application to
request the inventor to restrict
only one claim.
An unusual feature of the
Japanese patent sys- Aplications are examined
tem is that in the order
applications are not automatically were filed automatically. they
examined. The applicant has 7
years from the
filing date to file a request for examination.
5 Recentchanges to japanese patent law in 1996 There is
included the move from a re-examination procedure, where
a
pre-grant patent anyone can
present reasons and evidence to the
opposition system (3 months to file opposition) USPTO to challenge the
to a
post-grant oppósition system (6 months validity of a granted pat-
ent. It does not work the
to file opposition, but the same as an
patent is valid until opposition.
declared otherwise)

Japanese patent law says patent infringement

is a crime. A Infringement is not a crime,
person who has infringed a patent, not intended.as a
and damages are
right must be engaged in penal servitude for at penalty.
most 5 years, or must
pay a fine of at most
5 million yen (Article 196).
..... 7.......If the invention has become publicly available There is
in any way, by the inventor or anyone else, 1-year grace period (35 US Code
a
Section 102), which means that the inventor
before the filing of patent application, the
can freely
application will be rejected. publish his invention without losing
patent rights.
 Law 45
History and Evolution of Patent

ced by the Pat- CHAPTER SUMMARY

mpletely revised the
1959, Thus, the basic principles to grant
treaties provide interna-
Osition proceed- The patent laws have evolved from very ear is a member of several
to be patent. India like WIPO,
and treaties
in relation to the ly times and are generalBy considered also tional organizations and Budapest
evolved in ltaly in 1474. Patents
were
Convention, PCT
WTO, Paris the promo-
motivate and protect responsible for
given by the Queen to indus- Treaty, which are
resulted in of intellectual property
the foreign engineers, which tion and protection
nation and brought
trial development of the throughout the world.
in 1474. Difer of the United
Industrial Revolution in Italy WIPO is specialized agency
a
evolution of that the rights
varied ways of dedicated to ensuring
ent countries have Nations,
to start the intellectual property
laws but the basic purpose owners of
patent intellec- of creators and
support the worldwide. WTO is the
succes-
was to
patenting system invention which
are protected
to the GATT
and is one of
tual creativity and encourage
sor organization
industrialization. The modern of the United Nations,
e order they
resulted in rapid the important agencies
was created in 1791. Earlier, the better and wider protection
patent system which provides
office findsa granted without the
examination
holders of the devel-
ise patents were
to be for the private patent
since the inventor's right
was considered
nations than the
Paris Convention. The
ones.
oped which came into effect
natural and original TRIPS Agreement,
only one cdaimed The first patent law in India was passed on is to date the most com-
on 1 January 1995,
mines that there which received the assent on intel-
28 February 1856, law prehensive
m u l t i l a t e r a l agreement

tion in the ap- General (GG) and the standards for the
of the Governor 2006. lectual property. It provides
entor to restrict several amendments till property rights
and
went through full range of intellectual
not found in the
m.
provisions which were
of those standards both
The
follows: also the enforcement administra-
Indian Patent Act
1970 are as
legal and
e order they internally and through
be extended by
T h e term of patent could not tive actions. PCT is a treaty
administered

General (GG). inter-

by Governor rise to 'centralized
inven- WIPO, which gives
treated as for the grant
T h e importers were also national application procedure'
to know-how and practices and regiona! level.
PCT
tors subject of patent at national Conven-
dure, where within a specified period. members of the Paris
1 evidence to the
is open to the
There was no provision for provisional tion and helps in filing
the separate patent ap-
of a granted pat- countries. PCT is one of
S an opposition.
specification.
not plication in member Bu-
used by the inventor were
conventions apart from
Inventions the international
considered to be for public use. dapest Treaty (for deposit of microorganism)
to varieties
have also been made (for the protection of
new
Presently changes The work-
UPOV
repression
1 damages are
make the patent rules
user-friendly. of plant), Madrid Agreement (for
decen- on
of
has also been
source

of the Patent Office deceptive indication

ing activities can
ot
alse or deposit
tralized completely.
All patent goods), Madrid Protocol (concerning
offices International Union
the patent
be carried on by all
ndustrial design). The
now
Kolkata and Chennai): Ear-
ot Varieties of Plants
(Delhi, Mumbai, the Protection of New
for
activities could be carried was
the International
established by
5 US Code lier certain patent (UPOV)
Head Office (Patent
Office
Convention for the
Protection of New Vari-
the inventor out only by the
Patent Oftice the rights of the
without losing at Kolkata) also
the fees to the eties of Plants and protects
Patents have
breeders. To have the plant variety
right,
can now be paid electronically. plant
and the international
gained global recognition
46 IPR, Biosafet and Bioetitiecs heEuro-
wniie
nata
patent laws are strict. The Euro-
ysigned
the requirement
of nov- is a treaty signed by
Fatent Convention
The plant should fulfil
stability. pean countries. Patents under
the EPC lo. t h e

uniformity and 27 European

ety, distinctiveness,
another treaty
formed to de
by the European
Patent Office
Budapest treaty is at the
international
are
granted law is very
n Munich. Chinese patent
posit the microorganismsAmerican Type Cul- (EPO) and US patent laws with a
depository authority like Microbial Type
close to European

ture Collection (ATCC)

and
few exceptions. The only problem that China
Culture Collection (MTCC). n o w is effective enforcement of its
Is facing
so there
Patents are granted country-wise, law and implementation. While in
case

different patent laws in

diferent countries. patent
are
remain same of Japan, the procedure for grant of patents is
However, some basic features similar to that of India.
liberal to a very small extent
laws are
in every country. US patent Chapter o
It is evid
ents are
MULTIPLE CHOICE QUESTIONS
utility par
to issue conmpulsory licences as 4. GATT was replaced by gineering
1. The provisions
made in the year i) TRIPs Gi) WIPO products,
i) 2002 (i) 2005 (ii) WTO (iv) None
(ii) 1970 Civ) 2006
5. Which country follows the first-to-invent
2. Pre-grant and post-grant oppositions can be filed The patent syste
principle?
in the patent office after effective from 2
(i) lapan I January, 199
(i) 2002 amendment
(ii) India
ii) 2005 amendment 1999. The pater
(iii) United States
(iii) 2006 amendment or a product its
(iv) China
(iv) None gives exclusive
3. How many rounds are held by GATT? to sell or impor
) 5 rounds to prevent the tl
(i) 6 rounds ing to sell, selli
(ii) 7 rounds India is a u
iv) 8 rounds Organization (
protection of in
zation has diffe

REVIEW QUESTIONS The term ofth

criteria are that
1. How many amendments
were done to the Indian Patent Act 1970? Discuss. in the process.
2. Why countries become members
of International conventions and treaties? Discuss the advan- or a product th:
tages.
3. What changes were seen in the Indian
pharmaceutical sector after the TRIPs agreement?
4. What requirements can be fulfilled by theplant to obtain Plant Variety Right?
CLASSIFICA
5. How the Indian patent laws
are The need for ci
different from US patent laws?
6. What are the major tion contained
points of difference between the US and UK patent laws? Discuss. such as title, at
a particular are
invention must
granting autho: